Objective: The formulation process of torasemide injection was optimized. Methods: The formulation and preparation technology of torasemide injection were determined by screening the types of excipients, the range of pH value, the proportion of activated carbon dosage and sterilization conditions. Results: The best prescription is torasemide 5 g, polyethylene glycol 400 100 g, tromethamine 2 g, sodium hydroxide 0.5 g, water for injection 1 000 mL. The range of pH value was determined to be 9.00±0.20; the dosage of activated carbon was 0.10 %; the sterilization conditions were 121 ℃ for 15 min. The results of process verification and stability test show that the prescribed process is feasible. Conclusion: The torasemide injection product determined by this prescription and technology has stable quality and good safety.
LI Puchao
,
LIU Quanli
. Study on the formulation process of Torasemide injection[J]. Journal of Baotou Medical College, 2023
, 39(10)
: 79
-83
.
DOI: 10.16833/j.cnki.jbmc.2023.10.016
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